Using laser imaging to monitor blood flow during breast reconstruction
The Clinical and Cost Effectiveness of Intra-operative Laser Speckle Imaging (LSI) of Tissue Blood Flow to Avoid Post-operative Complications Following Breast Reconstruction After Mastectomy for Breast Cancer: A Feasibility Study
This study is testing a new laser imaging device to see if it can help doctors monitor blood flow during breast reconstruction surgery for women who have had cancer, with the aim of improving healing and reducing complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Royal Devon and Exeter NHS Foundation Trust Academic / other |
| Locations | 1 site (Exeter, Devon) |
| Trial ID | NCT06523452 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of a new laser speckle imaging device to monitor blood flow in women undergoing breast reconstruction surgery after cancer. The device provides immediate, continuous images of skin blood flow, helping surgeons identify areas at risk for healing complications. By assessing blood flow during surgery, the goal is to improve patient outcomes and reduce the incidence of healing problems that can arise post-operation. The study focuses on women scheduled for autologous free flap breast reconstruction, either immediately after mastectomy or at a later date.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 or older who are scheduled for breast reconstruction surgery using autologous free flap techniques.
Not a fit: Patients who are unable to provide informed consent or are not scheduled for breast reconstruction surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce healing complications and improve recovery for women undergoing breast reconstruction.
How similar studies have performed: While this specific approach is novel, similar imaging techniques have shown promise in other surgical contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female, aged 18 or over; * Able and willing to provide informed consent; * Scheduled for breast reconstruction by autologous free flap surgery (either immediately post-mastectomy or delayed). Exclusion Criteria: * Unable to give written informed consent.
Where this trial is running
Exeter, Devon
- Royal Devon University Healthcare NHS Foundation Trust — Exeter, Devon, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Lucy Gates, PhD
- Email: lucy.gates1@nhs.net
- Phone: 01392 408181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.